Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
30
Countries
1
Sites
1
giant cell arteritis - polymyalgia rheumatica spectrum disease
To assess the diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-04-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University Medical Center Groningen · Siemens Healthineers
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Diagnosis
To assess the diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.
Secondary objectives 2
- To determine the 68Ga-FAPI-46 uptake after 28 days of standard treatment in patients with GPSD.
- To determine the 68Ga-FAPI-46 uptake after 6 months of standard treatment in patients with GPSD.
Conditions and MedDRA coding
giant cell arteritis - polymyalgia rheumatica spectrum disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10018250 | Giant cell arteritis | 10047065 |
| 21.0 | PT | 10036099 | Polymyalgia rheumatica | 100000004859 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-511977-31-00 | 68Ga-FAPI-46 PET for Giant Cell Arteritis-Polymyalgia Rheumatica Spectrum Disease | Universitair Medisch Centrum Groningen |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients with suspected GPSD. In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age ≥ 50 years - Patients must be able to adhere to the study appointments and other protocol requirements. - Patients must be capable of giving informed consent
Exclusion criteria 1
- Patients with suspected GPSD. A potential subject who meets any of the following criteria will be excluded from participation in this study: - Suspected GPSD, - Presence of symptoms, imaging test result or biopsy findings suggesting cranial artery involvement in GPSD (‘cranial giant cell arteritis’) - Use of oral glucocorticoid treatment or disease modifying anti-rheumatic drugs at time of inclusion - Females with child bearing potential. Post-menopausal women with >12 months of amenorrhoea are considered to have no child bearing potential. Given the age distribution of patients with GPSD, exclusion of females with child bearing potential will not lead to recruitment bias in the study. - Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.
Secondary endpoints 2
- 68Ga-FAPI-46 uptake after 28 days of standard treatment in patients with GPSD.
- 68Ga-FAPI-46 uptake after 6 months of standard treatment in patients with GPSD
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11595253 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Substance synonyms
- 68Ga-FAPI-46
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- Max daily dose
- 250 MBq megabecquerel(s)
- Max total dose
- 750 MBq megabecquerel(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITY MEDICAL CENTER GRONINGEN
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- K.S.M. van der Geest
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- K.S.M. van der Geest
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Umcg
Rheumatology and Clinical Immunology, Hanzeplein 1, 9713 GZ, Groningen
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511977-31-01 | 6 |
| Protocol (for publication) | D1_Protocol_2024-511977-31-01_Redacted | 5 |
| Protocol (for publication) | D1_Protocol_2024-511977-31-01_TC | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_TC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_GPSD_2024 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_GPSD_2024_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_GPSD_2024_TC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_NL_2024-511977-31-01 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_NL_2024-511977-31-01_TC | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-24 | Netherlands | Acceptable 2026-04-14
|
2026-04-14 |